BIO08023 2011 BIOPHARMACEUTICAL SCIENCE PRACTICAL
This Biopharma laboratory practical module will provide students with practical knowledge, know-how and skills associated with upstream cell-culture processing and downstream protein purification in a typical modern biopharmaceutical processing facility. The relevant learning is achieved through the completion of a sequence of laboratory-based and pilot-plant based practicals and experiments that are designed to impart the required expertise. There will also be some research project work associated with the laboratory practicals.
On completion of this module the learner will/should be able to;
Demonstrate a range of practical know-how and skills associated with relevant, lab-based and pilot-plant based upstream bioprocessing equipment.
Demonstrate a range of practical know-how and skills associated with relevant, lab-based and pilot-plant based downstream bioprocessing equipment.
Perform some defined research project work related to the lab. practicals and interpret and critically evaluate the data and results obtained from this project work.
Take responsibility for and direct the work of other individuals in a quasi-GMP environment.
Demonstrate effective communication skills both orally and in written format.
Module Assessment Strategies
The assessment strategy will comprise of both observation of skills being acquired as well as formal assessment of knowledge acquisition. There will be a project research element associated with the assessment strategy also.
The range of lab-based and pilot-plant based upstream practicals may include some or all of the following items: aseptic techniques; cell culture techniques including cell counting (both manual and automated), sub-culturing including media exchange, thawing up and freezing-down of cells; benchtop bioreactor techniques such as disassembly/reassembly of parts, bioreactor instrument calibration, preparation for autoclaving, inoculation and operation, sampling and substrate analysis. P+ID (Piping and Instrumentation Diagrams) analysis work on bioreactor systems; CIP cycle operation on bioreactor systems; SIP cycle operation on bioreactor systems; cell culture run on the bioreactor vessel; operation of the perfusion skid system for the bioreactor vessel; calibration of pH and DO instruments.
The range of lab-based and pilot-plant based downstream practicals covered may include some or all of the following items: filter integrity testing; centrifugation for cell separation purposes; buffer preparation; specific chromatography practicals based around different chromatography columns; cell separation/cell debris removal using hollow-fibre microfiltration; protein concentration using ultrafiltration; protein concentration and buffer exchange using ultrafiltration / diafiltration; disc-stack centrifugation for cell separation; depth filtration and microfiltration; industrial-scale filter integrity testing; column packing; theory and practice of industrial-scale chromatography skids; theory and practice of industrial-scale ultrafiltration / diafiltration skids; normal flow filtration.
Research project work related to the upstream and downstream practicals previously undertaken - may be individual or group-based project.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Practical Evaluation Observation assessment of practical skills.||Continuous Assessment||UNKNOWN||20 %||Week 1||1,2|
|2||Open Book Exam Exam at end f day 1 of lab. practicals.||Continuous Assessment||UNKNOWN||20 %||Week 1||1,2,3|
|3||Open Book Exam Exam at end of day 2 of lab. practicals.||Continuous Assessment||UNKNOWN||20 %||Week 1||1,2,3,4|
|4||Project Research project based around the lab. practicals.||Continuous Assessment||UNKNOWN||40 %||Week 14||1,2,3,4,5|
Part Time Mode Workload
|Lecture||Not Specified||Preparatory study material for lab. practicals.||4||Once Per Semester||0.27|
|Laboratory Practical||Science Laboratory||Attendance at laboratory practicals.||16||Once Per Semester||1.07|
|Independent Learning||UNKNOWN||Research project based on lab. practicals.||3||Weekly||3.00|
Walsh, Gary. 'Pharmaceutical Biotechnology'. Wiley. 2007.
Ratledge, Colin and Kristiansen Bjorn. 'Basic Biotechnology'. Cambridge Press. 2001.
Doran, Pauline M. 'Bioprocess Engineering Principles'. Academic Press. 1995.
Hatti-Kaul, Rajni and Mattiasson, Bo. 'Isolation and Purification of Proteins'. Marcel-Dekker. 2003.